Ketoprofen Lyophilized Injection

Product/Composition Ketoprofen Lyophilized Injection
Strength 100mg
Form Lyophilized Injection
Production Capacity 1 Million Lyophilized Injection/Month
Therapeutic use Cardiovascular
Package Insert/Leaflet Available upon request

Ketoprofen Lyophilized Injection is a parenteral dosage form of ketoprofen, a non-steroidal anti-inflammatory drug (NSAID). It is usually prepared as a lyophilized (freeze-dried) powder that requires reconstitution with a suitable diluent before administration.

Here are the key details:

1. Composition and Form:

  • Contains ketoprofen, an NSAID from the propionic acid derivative group.

  • Supplied as a sterile lyophilized powder in vials.

  • Reconstituted with sterile water or other approved solvent before intravenous (IV) or intramuscular (IM) injection.

2. Mechanism of Action:

  • Inhibits cyclooxygenase (COX-1 and COX-2) enzymes, leading to reduced prostaglandin synthesis.

  • Provides analgesic, anti-inflammatory, and antipyretic effects.

3. Indications:

  • Acute pain management (postoperative, musculoskeletal, trauma-related).

  • Inflammatory conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

  • Short-term relief of moderate to severe pain where oral administration is not possible.

4. Administration:

  • Usually given intramuscularly or intravenously after reconstitution.

  • Dose and frequency depend on severity of pain, patient’s condition, and physician’s guidance.

5. Side Effects:

  • Gastrointestinal irritation, nausea, vomiting, abdominal pain.

  • Risk of peptic ulcer, GI bleeding, or perforation with prolonged use.

  • Dizziness, headache, somnolence.

  • Renal function impairment in susceptible patients.

  • Rare hypersensitivity or anaphylactoid reactions.

6. Contraindications:

  • History of hypersensitivity to ketoprofen or other NSAIDs.

  • Active gastrointestinal ulceration or bleeding.

  • Severe renal, hepatic, or heart failure.

  • History of aspirin/NSAID-induced asthma or allergy.

7. Precautions:

  • Use cautiously in elderly patients and those with cardiovascular risk.

  • Monitor renal and liver function during therapy.

  • Avoid prolonged use in parenteral form; switch to oral formulations when possible.

8. Storage:

  • Store vials in a cool, dry place, protected from light.

  • Reconstituted solution should be used promptly or within the recommended stability period.